Fourth Circuit Expedites Appeal, but District Court’s May 12 FDA Premarket Review Deadline Remains For Now

On January 21, 2020, the U.S. Court of Appeals for the Fourth Circuit issued an order disposing of several motions before it in American Academy of Pediatrics, et al. v. U.S. Food & Drug Administration, et al., Nos. 19-2130, -2132, -2198, -2242. This is an appeal from the U.S. District Court for the District of Maryland, which:

held that the FDA’s August 2017 guidance did not lawfully extend tobacco product compliance deadlines; and

ordered new deadlines of May 12, 2020, for filing applications, and one year after application for approval.

The district court’s rulings amounted to a roughly two-year acceleration of the FDA’s deadlines.

Although the motions before the Fourth Circuit were largely procedural in nature, a motion to expedite and stay implicated the May 12 deadline itself. Given the fast-approaching deadline and difficulties in meeting it, the industry parties asked the Fourth Circuit to stay the district court’s order so the appeal could be heard and decided without irreparable harm to the industry parties in the meantime. Similarly, the industry parties asked the Fourth Circuit to expedite the appeal by scheduling oral argument during the court’s March 2020 session. Absent a stay, they requested a decision before May 12. The FDA opposed the stay but consented to expedited review. The plaintiffs (doctors, public health groups, and anti-tobacco advocacy groups) opposed the stay and were silent as to expedited review.

The Fourth Circuit’s January 21 order allowed for the expedited consideration of the merits but denied the stay. Consistent with the expedited review, oral argument has been set for March 18 and accelerated briefing is scheduled to close on February 27.

While this is an important case to monitor, stakeholders would be well-advised to assume that the May 12 deadline could remain in place. Even though the parties and the court are on an expedited schedule, there is no guarantee when (much less how) the Fourth Circuit may rule, and there may be little to no time to react. The district court’s May 12 deadline is set to expire only about two and a half months after briefing closes and less than two months after oral argument.

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